WALTHAM, Mass. — Prilenia Therapeutics B.V. has entered into a data use agreement to provide CHDI Foundation with clinical data from the placebo arms of two Huntington’s disease studies, the company said.
Under the agreement, CHDI will receive placebo-arm clinical data from Prilenia’s PRIDE and PROOF studies to support research into Huntington’s disease treatments.
“Collaboration which balances scientific rigor with data openness is an ethical and scientific imperative. Sharing data is key to accelerating and advancing knowledge and understanding and accelerates progress aimed at the development of much needed treatments capable of diminishing the effect of intractable diseases such as HD,” said Dr. Michael R. Hayden, Prilenia’s Chief Executive Officer. “Patients are at the center of this initiative; it is vital to foster an ecosystem where we can all work together to fully utilize high-quality data to enable future innovation for the benefit of people living with HD.”
CHDI Foundation supports research aimed at developing treatments for Huntington’s disease. Robi Blumenstein, president of CHDI Management, which manages CHDI Foundation’s scientific activities, said the donated data could help researchers better understand placebo effects in clinical trials.
“Prilenia’s gifting of these data will help us better understand how placebo-related effects influence clinical trial outcomes, which could improve the design and interpretation of future trials and ultimately support the development of more effective approaches to slow the progression of this devastating disease. A better understanding of placebo effects could also help strengthen the validation of external comparator approaches, including those derived from the Enroll-HD dataset.”
Under the agreement, CHDI receives a worldwide, non-exclusive license to use individual patient-level data from placebo patients in the two studies. CHDI will own any research results it generates using the data and may make the data available to qualified third-party research institutions and companies.
Prilenia will retain ownership of the underlying data. The company said all data will remain securely coded and anonymized to protect study participants’ identities. Any publications resulting from the research may include a Prilenia author and will acknowledge the company as the source of the data.
Huntington’s disease is a rare, inherited neurodegenerative disease that causes functional, motor, cognitive and behavioral symptoms and ultimately leads to death. The disease is caused by a mutation in the huntingtin gene, and each child of a parent with Huntington’s disease has a 50 percent chance of developing it.
An estimated 100,000 people worldwide have Huntington’s disease, with about 300,000 additional people at risk of developing it. The disease is typically diagnosed between ages 30 and 50, although it can occur at any age, including in children and young adults. Huntington’s disease generally progresses over 15 to 20 years, gradually impairing a patient’s ability to work, communicate, manage daily life and care for themselves.
Current treatments focus on symptom relief and palliative care. Prilenia said a potential registrational Phase 3 study of pridopidine in early- to mid-stage Huntington’s disease is planned to begin in the second quarter of 2026.
